Orthopaedic trauma clinical research: is 2-year follow-up necessary? Results from a longitudinal study of severe lower extremity trauma

J Trauma. 2011 Dec;71(6):1726-31. doi: 10.1097/TA.0b013e31822c1c33.


Background: The ideal length of follow-up for orthopedic trauma research studies is unknown. This study compares 1- and 2-year complications, clinical recovery, and functional outcomes from a large prospective clinical study.

Methods: Patients (n = 336) with limb threatening unilateral lower extremity injuries were followed at the 12, 24, and 84 months. Major outcomes observed were complications requiring hospital re-admission, fracture and wound healing, attainment of full weight bearing status, return to work, and self-reported functional outcome using the Sickness Impact Profile.

Results: The rate of newly observed complications beyond year 1 was small, ranging from 0 to <2%. In addition, 85% to 90% of the clinical recovery outcomes were attained by 1 year, and patients not achieving clinical recovery during the first year had significantly worse functional outcomes. Only 5% of patients returned to work between 1 year and 2 years. Although, a substantial number of patients achieved functional recovery between 1 year and 2 years, of the patients not achieving functional recovery at year 1, 85% of those who would go on to achieve functional recovery during the second year could be predicted using year 1 data.

Conclusions: Although long-term follow-up provides a more complete picture of final outcomes and rate of recovery, follow-up beyond 1 year is difficult and expensive. In our study, it accounted for 20% of the total cost. The analysis of our data suggests that 1-year data were sufficient to address our major study hypotheses.

Publication types

  • Comparative Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Cohort Studies
  • Female
  • Follow-Up Studies
  • Health Services Research
  • Humans
  • Injury Severity Score
  • Leg Injuries / diagnosis*
  • Leg Injuries / surgery*
  • Limb Salvage*
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Monitoring, Physiologic / methods*
  • Orthopedic Procedures / adverse effects
  • Orthopedic Procedures / methods*
  • Postoperative Complications / epidemiology
  • Postoperative Complications / physiopathology
  • Recovery of Function
  • Sickness Impact Profile
  • Time Factors
  • Treatment Outcome
  • Young Adult